News
May 2025
Treatment efficacy and safety of adalimumab versus tocilizumab in patients with active and severe Takayasu arteritis: an open-label study
Summary
The management of Takayasu arteritis (TAK) remains challenging due to its relapsing nature, often requiring long-term therapy over years. Given the risks of refractory disease and glucocorticoid-related (GC) toxicity, safe and sustained GC-sparing strategies are essential. The 2021 ACR/VF guidelines currently favor tumor necrosis factor inhibitors (TNFi) over tocilizumab (TCZ) as initial therapy, based on greater clinical experience and supporting data [1]. However, direct comparative studies are lacking. By providing head-to-head efficacy and safety data on adalimumab (ADA) versus TCZ, the study aims to clarify which biologic agent may offer superior short-term and long-term benefits in patients with active and severe TAK [2].
This randomized, controlled, open-label study enrolled 40 patients who were treated with either ADA (n=21) or TCZ (n=19), both combined with GCs and methotrexate. The primary endpoint was the efficacy rate (ER) at 6 months, with secondary endpoints including ER at 9 and 12 months, relapse rate, GC tapering, adverse effects, and quality of life changes during treatment.
The results demonstrated that the ER at 6 months was significantly higher in the ADA group compared to TCZ in the intention-to-treat population (P=0.02), with a similar trend observed in the per-protocol analysis (P=0.06). By 9 and 12 months, efficacy rates were comparable between groups. The proportion of patients achieving glucocorticoid tapering to ≤10 mg/day at 6 months did not differ significantly (P=0.83). Relapse rates and adverse event frequencies over the 12-month follow-up were also similar (P=0.96 and P=0.55, respectively). For detailed statistics, see the following table.
| 
 Outcome  | 
 Adalimumab (ADA)  | 
 Tocilizumab (TCZ)  | 
 P-value  | 
| 
 Patients enrolled  | 
 21  | 
 19  | 
 
  | 
| 
 ER at 6 months (ITT)  | 
 85.71% (18/21)  | 
 52.63% (10/19)  | 
 0.02  | 
| 
 ER at 6 months (Per-protocol)  | 
 89.47%  | 
 62.50%  | 
 0.06  | 
| 
 ER at 9 months  | 
 61.90% (13/21)  | 
 42.11% (8/19)  | 
 0.21  | 
| 
 CR rate at 9 months (ITT)  | 
 47.62% (10/21)  | 
 42.11% (8/19)  | 
 0.73  | 
| 
 CR & ER at 12 months  | 
 57.14% (12/21)  | 
 26.32% (5/19)  | 
 0.05  | 
| 
 Patients completing 12-month treatment  | 
 12  | 
 8  | 
 
  | 
| 
 GC dose ≤10 mg/day at 6 months  | 
 47.37%  | 
 43.75%  | 
 0.83  | 
| 
 Relapse Rate (12 months)  | 
 9.52%  | 
 10.53%  | 
 0.96  | 
| 
 Adverse Events (12 months)  | 
 38.10%  | 
 47.37%  | 
 0.55  | 
Impact on Patient Treatment and Future Perspectives
This study suggests that ADA, in combination with glucocorticoids and methotrexate, may offer superior short-term efficacy compared to TCZ in patients with active and severe TAK. These findings support the 2021 ACR/VF guideline recommendation favoring TNFi over TCZ as initial biologic to facilitate GC-sparing, reinforcing ADA’s role as a preferred first-line agent for remission induction. Nonetheless, the comparable long-term efficacy and safety profiles observed between ADA and TCZ indicate that TCZ remains a valid alternative, particularly for patients with intolerance or contraindications to TNFi.
References:
1. Maz M, Chung SA, Abril A, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Care & Research. 2021;73(8):1071-1087. doi:10.1002/acr.24632.
2. Wang J, Kong X, Ma L, et al. Treatment Efficacy and Safety of Adalimumab Versus Tocilizumab in Patients With Active and Severe Takayasu Arteritis: An Open-Label Study. Rheumatology (Oxford, England). 2024;63(5):1359-1367. doi:10.1093/rheumatology/kead387.
Composed by
Dr. med. Andrea Gloor
Assistenzärztin, Universitätsklinik für Notfallmedizin
Inselspital, Universitätsspital Bern
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